Early Versus Interval Appendectomy for Ruptured Appendicitis in Children

Phase 3

Completed

• Conditions: Ruptured Appendicitis
• Interventions: Procedure: early appendectomy; Procedure: interval appendectomy

• Registration Number: NCT00435032
• Lead Sponsor: University of Tennessee

Brief Summary

The purpose of this randomized trial is to compare two commonly utilized surgical treatments for children with ruptured appendicitis: early appendectomy, versus interval appendectomy. The primary outcome measure is time away from normal activities.

Detailed Description

There are two surgical treatment options for children with ruptured appendicitis. Early appendectomy is one option and typically involves removing the ruptured appendix after several hours of optimizing the patient medically with intravenous fluids and intravenous antibiotics. Another option, interval appendectomy, uses the same initial fluid and antibiotic management, but delays removing the appendix until 6-8 weeks later. The rationale for delaying the appendectomy is to perform the operation at a time when the patient is perhaps more stable and the abdominal cavity is free from contamination. Both of these treatment options are currently used by many pediatric surgeons across the United States and both appear to work well. The two treatment have never been compared in any prospective study. The primary outcome of the study is the time that a patient (and family) is away from normal activities, due to the disease and its treatment. Secondary outcome measures include complication rates, quality of life measures (SF10), hospital cost analysis, and others.

Study Timeline

• Study Start: 2006-10
• Study First Submitted: 2007-02-12
• Study First Submitted QC: 2007-02-13
• Study First Posted: 2007-02-14
• Primary Completion: 2009-09
• Status Verified: 2010-01
• Last Update Submitted: 2010-01-11
• Last Update Posted: 2010-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 128

Inclusion Criteria

• Clinical diagnosis of ruptured appendicitis

Exclusion Criteria

• Inability to have usual follow up care (e.g. transient to area)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	early appendectomy	Early appendectomy
2	interval appendectomy	Interval appendectomy

Primary Outcome Measures

Name	Time	Method
time (days) away from normal activities (or time until returns to normal activities)	At completion of study

Secondary Outcome Measures

Name	Time	Method
Requires reoperation	Throughout study period
Bowel obstruction	Throughout study period
central venous catheter-related infection	Throughout study period
complication rates of each treatment arm:	At completion of study
Wound infection or dehiscence	Throughout study period
Intra-abdominal abscess	Throughout study period
interventional radiology-related complication	Throughout study period
Total hospital length of stay	At study completion
# patients with central venous line	At study completion
# with interventional radiology drainage	At study completion
# of return visits to pediatrician, ED, surgery office	At study completion
Other complication	At study completion
quality of life questionnaire (SF10)	At diagnosis, at hospital discharge, one month after diagnosis and one month after completion of all treatment
hospital costs	At study completion

Trial Locations

Locations (1)

LeBonheur Children's Medical Center; 🇺🇸 Memphis, Tennessee, United States